Ogmend® Implant Enhancement System

Ogmend® Implant Enhancement System is an FDA 510(k)-cleared medical device (K223075) manufactured by Woven Orthopedic Technologies. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2023. Regulation: 8.